Preventative maintenance programs, validation support, control system upgrades, freeze drying cycle development, training, upgrades and refurbishments, are just some of the value-adding services we can offer.
Investigate new technologies developed internally or introduced by our customers:
Process analytical tools
Quality by Design modeling
Syringe and vial heat transfer coefficient studies
Shelf heat transfer enhancements
We can offer assistance in the following areas:
Assistance with infrastructure and system design
Clinical and commercial
New and renovated
Compliant material and personnel flows
Throughput analysis and choke point identification
Equipment specification writing, and testing
Compliance gap analysis
Discrete failure analysis
Product impact analysis
Recent trends in the pharmaceutical industry have highlighted the importance of technology transfer. Mergers and acquisitions, the growth of generics, the closing of plants, and the construction of new ones are all activities that typically involve the transfer of products and processes from one site to another.
New products and methods must also be moved from the development site to a manufacturing site prior to launch. Technical transfer is a specific function required by all Bio-Pharm companies. Technology transfer is critical for the ability to provide uninterrupted supply and the drive to achieve greater efficiency and cut costs.
Our team can assist with:
Facility construction – space, load, proximities, infrastructure, validation
Equipment specifications – capacity, precision, speed, materials of construction, validation
Analytical transfer – equipment, method assessment, validation
Process requirements – engineering runs, stability lots, process validation
Regulatory requirements – change notification, documentation packages (SOP’s, MBR’s, protocols, summary reports), data review and analysis, PAI readiness
Several training modules can be delivered at the Tonawanda Lyo Process Lab for hands-on experience, or delivered either at the customer site. Qualified personnel with expertise in the subject matter teach the trainings described below.
INTRODUCTION TO LYOPHILIZATION (FREEZE-DRYING) AND CYCLE DEVELOPMENT
Overview of the lyophilization process: theory, equipment, formulation, analytical support, validation, cycle development and scale-up.
Duration: 3 days (4h lectures and 4h laboratory activities each day).
Basics of clean room operations, basic microbiology, aseptic techniques, gowning, clean room design and control, environmental monitoring, glassware and equipment preparation, solution processing (compounding), sterilization and filtration, process simulation/media fill, formulation and drug development.
Duration: 4h lectures.
CURRENT GOOD MANUFACTURING PRACTICE (cGMP)
Application of cGMP in the production of pharmaceuticals developed using biotechnology (biopharmaceuticals). Selections from Title 21 of the CFR 210/211, and relevant ICH and FDA guidance document.
Duration: 4h lectures.
Our highly skilled professionals have an extensive experience gained in the field of parenteral development and facility operation. Their technical experience includes freeze drying technology, aseptic processing, formulation, filtration science and sterilization.